Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations (LISPRAY)

Azienda Sanitaria-Universitaria Integrata di Udine

Status and phase

Completed

Phase 3

Conditions

Vaginal Discharge

Analgesia

Perineum; Rupture

Treatments

Drug: Mepivacaine Injection

Drug: Lidocaine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT05201313

0042698/P/GEN/ARCS

Details and patient eligibility

About

Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum, comparing it with the standard technique that involves the infiltration of lacerated tissues, by administering a NRS card at the end of the procedure.

Full description

The study aims to compare the effectiveness of pain treatment during the suturing of postpartum perineal lacerations with lidocaine spray vs skin infiltration. The hypothesis of the study is that the treatment of perineal pain with nebulization demonstrates comparable efficacy vs the infiltration of mepivacaine hydrochloride in a population of patients subjected to suturing of postpartum lacerations. Eligible women will be randomly assigned to receive, after wound disinfection and cleansing of bleeding with mild haemostasis:

nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm (experimental group).
subcutaneous / submucosal infiltration depending on the type of perineal laceration of 10 ml of 1% mepivacaine hydrochloride (control group).

Since there are no previous published studies, regarding the use of nebulized lidocaine hydrochloride for the suturing of perineal lacerations, the number of puffs chosen was chosen based on what is indicated on the technical data sheet of lidocaine hydrochloride and making use of previous studies in the gynecological field, but with other indications.

The suture will be made once anesthetic efficacy is achieved, as per pharmacological indications. The administration of the anesthetic and the suturing of the lacerations will be performed by the gynecologist or by the gynecology resident who will be working at that time in the delivery room, as is routinely done in our Clinic. The patients will be enrolled consecutively following the order generated by the randomization list itself. By filling in specific pre-set cards, the data will be collected.

Initially, the primary outcome was NRS at the beginning of suturing and NRS at the end of the procedure. In a second moment, the investigators thought it would be better to ensure that adequate analgesia (NRS<4) was achieved for all patients during suturing, rather than varying the dosage of the anesthetic itself. The investigators then decided to reassess pain at successive time points, evaluating it at 0, 2, 4, 12, and 24 hours.

Enrollment

136 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

have a 1st or 2nd degree postpartum perineal laceration requiring suturing;
have reached 37 gestational weeks;
are over 18 years of age;
had a top birth;
are able to understand the Italian language;
have a consent to participate in the study;

Exclusion criteria

have received epidural anesthesia within 2 hours prior to delivery;

had an operative birth;
have a psychiatric pathology;
have had a twin birth;
have experienced adverse reactions to any local anesthetic in the past;
hypersensitivity to the active substance or to any of the excipients
Severe disturbances of the cardiac conduction system
Acute non compensated heart failure
Severe arteriopathies
Severe uncontrolled hypertension
Intravascular injections
Septicemia Dysfunction
Infection at the injection site
Kidney failure. Providing for the exclusion of patients with severe renal impairment (estimated GFR <30 mL / min / 1.73 m2 at the time of screening).
Advanced liver dysfunction
Hyperthyroidism
Acute angle glaucoma
Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or 5 half-lives of the study drug
Any clinical condition that in the investigator's judgment would render the patient unsuitable for the study including, but not limited to, infectious, inflammatory, psychiatric, neurological, cardiological, renal, hepatic, respiratory, diabetes) conditions or laboratory value at clinically meaningful screening that, an investigator's opinion, may present a safety risk, interface with study compliance and follow-up;
have had in pregnancy liver disease including pre-eclampsia.